Industry News

Teva Pharmaceutical Industries Ltd. announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorization for CINQAERO® (reslizumab), a humanized interleukin 5 antagonist monoclonal antibody for add-on therapy in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus another medicinal product for maintenance treatment.

Genmab  announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a negative opinion for the use of Arzerra® (ofatumumab) as maintenance therapy for patients with relapsed chronic lymphocytic leukemia (CLL).  The Marketing Authorization Application (MAA) was submitted by Novartis in July 2015 under the ofatumumab collaboration between Novartis and Genmab.

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Supernus Pharmaceuticals, Inc., a specialty pharmaceutical company, announced the issuance on June 21, 2016 of a seventh patent (number 9,370,525) by the United States Patent and Trademark Office (USPTO) covering Oxtellar XR, its novel once-daily extended-release oxcarbazepine product. The patent provides protection for the product with expiration that is no earlier than 2027.

Angiochem, a biotechnology company developing proprietary peptide-drug conjugates uniquely capable of crossing the blood-brain barrier, announced the successful completion of an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) for ANG1005. As a result, the company is in final preparation stages to commence its Phase 3 trial to support a New Drug Application (NDA) for ANG1005 in patients with leptomeningeal carcinomatosis (LC) from breast cancer.

Incyte Corporation announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for ruxolitinib (Jakafi®) for the treatment of patients with acute graft-versus-host disease (GVHD). There are currently no approved treatments for patients with acute GVHD.

Collegium Pharmaceutical, Inc. announced the commercial launch of Xtampza ER (oxycodone) extended-release (ER) capsules in the United States. Xtampza ER was approved by the US Food and Drug Administration (FDA) for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

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Perrigo Company plc announced it has received final U.S. Food and Drug Administration clearance for three milk-based, store brand non-GMO infant formulas.  Shipments to retail customers have already commenced.

WAVE Life Sciences Ltd. announced that its lead candidate WVE-120101, which is being investigated for the treatment of Huntington’s disease (HD), has received Orphan Drug Designation by the U.S. Food and Drug Administration (FDA). WVE-120101 targets rs362307, a Single Nucleotide Polymorphism (SNP) that is associated with the disease-causing mutation in the huntingtin (HTT) gene. WAVE’s approach enables selective silencing of the disease-causing HTT allele, while leaving the healthy HTT allele to produce normally functioning protein.

Fate Therapeutics, Inc. announced  that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for ProTmune™ for the reduction of incidence and severity of acute graft-versus-host disease (GvHD) in patients undergoing allogeneic hematopoietic cell transplantation (HCT). In addition, the Company announced that its multi-center, randomized, controlled Phase 1/2 clinical trial of ProTmune in adult subjects with hematologic malignancies is open for patient enrollment.

Poxel SA announced positive results from the single ascending dose stage, which is the first stage of the ongoing PXL770 Phase 1 clinical trial. PXL770 is a first-in-class direct adenosine monophosphate-activated protein kinase (AMPK) activator, a key enzyme in energy metabolism acting as an energy sensor regulating glucose and lipid levels. AMPK activation is considered to mimic the effects of long-term exercise and plays an important role in diabetes management, especially for patients with cardiovascular risk factors.